Synthes Trial Spacers: Modified Manufacturing Process Hazard
Synthes recalls trial spacers with T-handle that were modified outside approved manufacturing. These devices may not function as intended due to improper production.
Lower-risk recall
Modified outside of approved manufacturing process
Contact the company
What happened, in plain English
Synthes is recalling trial spacers (7mm to 17mm with T-handle) that were modified during manufacturing. This could cause them to not work properly, potentially leading to incorrect surgical outcomes. Read more at govinfonow.com/recall/67067-synthes-trial-spacers-modified-manufacturing-process-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/67067-synthes-trial-spacers-modified-manufacturing-process-hazard · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0349-2020
Cite this page
“Synthes Trial Spacers: Modified Manufacturing Process Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67067-synthes-trial-spacers-modified-manufacturing-process-hazard. Based on FDA recall #Z-0349-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0349-2020%22&limit=1).
Why it’s dangerous
The spacers were made outside approved manufacturing processes, which could result in improper dimensions or functionality. This might cause the devices to not fit correctly during surgery, potentially leading to complications.
Who’s affected
Surgical professionals using these trial spacers for orthopedic procedures are most at risk. Patients who have received these devices may also be affected.
How to tell if you have this one
Check for trial spacers with T-handle and sizes from 7mm to 17mm. These were sold under the brand Synthes with unknown manufacturing details.
- Brand
Synthes- Category
Medical device
What to do — step by step
Check Product Details
Identify if your spacer has a T-handle and size between 7mm and 17mm.
Where it went and when
Where it was distributed
Distributed in Arkansas.
FDA distribution: “AR” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arkansas.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0349-2020 (September 5, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0349-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.